FDA Grants Fabhalta Traditional Nod, -48% eGFR Slope
Decision brief
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FDA granted traditional approval for Fabhalta (iptacopan) to slow eGFR decline in primary IgAN; APPLAUSE showed -3.0 vs -5.7 mL/min/1.73 m2/yr.
Key questions this brief answers
- What did the FDA traditionally approve Fabhalta for?
- What eGFR results supported the traditional approval?
- What safety program applies to Fabhalta in IgAN?
FDA Fabhalta traditional approval IgAN converts Novartis' oral Factor B inhibitor from an accelerated proteinuria claim to a traditional indication to slow kidney function decline in adults with primary IgA nephropathy at risk of progression, the company said on July 17, 2026.
Contents9 sections
Key Takeaways
- FDA granted traditional approval for Fabhalta (iptacopan) to slow kidney decline in primary IgAN.
- Prior accelerated approval (August 2024) covered proteinuria reduction; this decision followed priority review.
- APPLAUSE-IgAN: annualized eGFR slope -3.0 vs -5.7 mL/min/1.73 m2/yr for placebo over two years.
- REMS remains required because of encapsulated-bacteria infection risk.
Fabhalta IgAN at a glance
| Field | Detail |
|---|---|
| Product | Fabhalta (iptacopan), oral Factor B inhibitor |
| Company | Novartis |
| FDA action | Traditional approval announced July 17, 2026 (priority review) |
| Indication focus | Slow kidney function decline in adults with primary IgAN at risk of progression |
| Prior U.S. status | Accelerated approval August 2024 for proteinuria reduction |
| Pivotal trial | Phase III APPLAUSE-IgAN (NCT04578834) |
| Key eGFR result | -3.0 vs -5.7 mL/min/1.73 m2/yr annualized mean change (Fabhalta vs placebo) |
What did the FDA approve?
Novartis said the FDA granted traditional approval for Fabhalta to slow kidney function decline in adults with primary IgAN at risk of disease progression. The application received priority review after the drug's August 2024 accelerated approval for reducing proteinuria in primary IgAN.
Company detail is in Novartis' July 2026 GlobeNewswire Fabhalta traditional-approval release.
What did APPLAUSE-IgAN show?
Approval rested on Phase III APPLAUSE-IgAN. Over two years, Fabhalta's annualized mean eGFR change from baseline was -3.0 mL/min/1.73 m2/yr versus -5.7 for placebo. Novartis said Fabhalta slowed eGFR decline by 48% versus placebo and that proteinuria improvements appeared as early as two weeks and were sustained.
Trial design is registered as NCT04578834 on ClinicalTrials.gov: a randomized, double-blind, placebo-controlled Phase 3 study of iptacopan 200 mg twice daily on top of maximally tolerated ACE inhibitor or ARB therapy, with proteinuria and eGFR slope endpoints.
How does Fabhalta work in IgAN?
Fabhalta is an oral Factor B inhibitor that selectively targets the alternative complement pathway. Novartis positions alternative-pathway activation as a driver of glomerular inflammation and kidney damage in IgAN. The company said Fabhalta is the first complement inhibitor with traditional approval to significantly slow kidney function decline in primary IgAN.
What are the safety constraints?
Common adverse events in IgAN patients included abdominal pain, dizziness, and nausea. Fabhalta may raise the risk of serious infections from encapsulated bacteria and is dispensed only through a REMS program requiring vaccinations before treatment. Prescribers should follow the REMS vaccination and monitoring requirements in the July 2026 prescribing information.
What is next for IgAN care teams?
Traditional approval reframes Fabhalta from a proteinuria-focused accelerated claim to a labeled kidney-function–preservation indication. Teams should update pathways for adults at risk of progression, confirm insurance criteria tied to eGFR/proteinuria, and maintain REMS vaccination workflows. Novartis also cited an IgAN portfolio that includes Vanrafia (atrasentan) and investigational zigakibart.
Related coverage: Fabhalta Health Canada C3G approval, other recent oral chronic-disease FDA nods, and July 2026 U.S. FDA activity.
Frequently Asked Questions
What did the FDA traditionally approve Fabhalta for?
Novartis said the FDA granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta previously received accelerated approval in August 2024 for proteinuria reduction in primary IgAN.
What eGFR results supported the traditional approval?
In Phase III APPLAUSE-IgAN, Fabhalta showed an annualized mean eGFR change from baseline of -3.0 mL/min/1.73 m2/yr versus -5.7 mL/min/1.73 m2/yr for placebo over two years. Novartis said that equated to slowing eGFR decline by 48% versus placebo.
What safety program applies to Fabhalta in IgAN?
Fabhalta may increase the risk of serious infections caused by encapsulated bacteria and is available only through a REMS program that requires appropriate vaccinations before treatment. Common adverse events in IgAN included abdominal pain, dizziness, and nausea.
